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Tilavonemab in early Alzheimer's disease: results from a phase 2, randomized, double-blind study
Florian H, Wang D, Arnold SE, Boada M, Guo Q, Jin Z, Zheng H, Fisseha N et al.. Brain : a journal of neurology, 2023-06-01
Topic: Amyloid, tau and blood-test diagnosis
Tau accumulation in patients with Alzheimer's disease tracks closely with cognitive decline and plays a role in the later stages of disease progression. This phase 2 study evaluated the safety and efficacy of tilavonemab, an anti-tau monoclonal antibody, in patients with early Alzheimer's disease. In this 96-week, randomized, double-blind, placebo-controlled study (NCT02880956), patients aged 55-85 years meeting clinical criteria for early Alzheimer's disease with a Clinical Dementia Rating-Global Score of 0.5, a Mini-Mental State Examination score of 22 to 30, a Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index score of ≤85, and a positive amyloid PET scan were randomized 1:1:1:1 to receive one of three doses of tilavonemab (300 mg, 1000 mg, or 2000 mg) or placebo via intravenous infusion every 4 weeks.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Florian, H., Wang, D., Arnold, S. E., Boada, M., Guo, Q., Jin, Z., et al. (2023). Tilavonemab in early Alzheimer's disease: results from a phase 2, randomized, double-blind study. Brain : a journal of neurology. https://doi.org/10.1093/brain/awad024
Vancouver
Florian H, Wang D, Arnold SE, Boada M, Guo Q, Jin Z, et al. Tilavonemab in early Alzheimer's disease: results from a phase 2, randomized, double-blind study. Brain : a journal of neurology. 2023. doi:10.1093/brain/awad024. PMID: 36730056.
BibTeX
@article{florian2023-36730056,
author = {Florian, H. and Wang, D. and Arnold, S. E. and Boada, M. and Guo, Q. and Jin, Z. and Zheng, H. and Fisseha, N. and others},
title = {{Tilavonemab in early Alzheimer's disease: results from a phase 2, randomized, double-blind study}},
journal = {Brain : a journal of neurology},
year = {2023},
doi = {10.1093/brain/awad024},
pmid = {36730056},
url = {https://doi.org/10.1093/brain/awad024}
}
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Key findings
- This phase 2 study evaluated the safety and efficacy of tilavonemab, an anti-tau monoclonal antibody, in patients with early Alzheimer's disease.
- In this 96-week, randomized, double-blind, placebo-controlled study (NCT02880956), patients aged 55-85 years meeting clinical criteria for early Alzheimer's disease with a Clinical Dementia Rating-Global Score of 0.5, a Mini-Mental State Examination score of 22 to 30, a Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index score of ≤85, and a positive amyloid PET scan were randomized 1:1:1:1 to receive one of three doses of tilavonemab (300 mg, 1000 mg, or 2000 mg) or placebo via intravenous infusion every 4 weeks.
- The primary end point was the change from baseline up to Week 96 in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score.
- Safety evaluations included adverse event monitoring and MRI assessments.
Why it matters
This phase 2 randomized, double-blind, placebo-controlled trial tested the anti-tau antibody tilavonemab at three doses against placebo in patients with early Alzheimer's disease over 96 weeks. The available text does not report whether tilavonemab affected the primary endpoint.
Study details
- Study designclinical trial
- Participants108
- Effect size51.7%; 96.5%
- Evidence strengthHigh
How this study scored 82/100
Published in a leading specialty journal, and it is a randomized controlled trial. We have no data on senior author's track record, so that was left out: it earned 79 of the 96 points we could judge it on, which is 82 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Brain : a journal of neurology) |
| Journal's citation record | 4 / 4 | Brain: journal h-index 503 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomized controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2023 — within 6 year(s) of the newest study here |
| Sample size | 2 / 4 | 108 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomized / blinded | 2 / 2 | Randomized and blinded or placebo-controlled (as stated in the record) |
| Times cited | 5 / 7 | Cited 136 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 27.2 citations a year over 5 year(s) since 2023 |
| Impact for its field and year | 5 / 6 | Cited 20.0× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 7 other studies in this library |
| Still being cited | 3 / 4 | Cited 118 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | 3 / 3 | Harvard University: institution h-index 3,235 (OpenAlex) |
| Multicenter collaboration | 2 / 3 | OpenAlex lists 7 institution(s) in 3 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 36730056) |
| Free to read | 2 / 2 | Free to read |
| Points | 79 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 79 of the 96 points we could judge it on is 82 out of 100. |
| Total | 82 / 100 | — |
What each of these 20 components measures, and what this score is not →
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